Zydus Cadila’s COVID19 Vaccine Gets DGCI Approval For Human Trials
Human clinical trials for the COVID-19 vaccine by Zydus Cadila gets DCGI approval.
According to government sources, the Drugs Controller General of India (DCGI) has given approval to Zydus Cadila Healthcare for conducting human clinical trials of its COVID-19 vaccine candidate.
After the Ahmedabad based Zydus Cadila submitted their data of clinical trial on animals of its vaccine candidate to the DCGI, which was found to be successful with respect to immunogenicity and safety, the assent for the human trials was approved.
Considering the emergency and unmet medical need during the pandemic, the approval process was fast-tracked following a recommendation by the subject expert committee on COVID-19.
According to an official source, “After the animal studies of the potential novel coronavirus vaccine developed by Zydus Cadila Healthcare Ltd were found to be successful, DCGI Dr. V G Somani has given approval for the phase I and II clinical trials (on humans) for the vaccine candidate.”
The enrolment of subjects is likely to start soon, said the company. The source said, “To complete the phase I and II trials, it will take around three months.”
Currently, there are over 110 independent scientific bodies in contention to find a potential COVID-19 vaccine, with over 10 million cases reported globally. In just this week, India has two vaccine candidate groups approved to begin human clinical trials for their prototypes, along with over 7 vaccines being researched in India. The country’s first indigenous COVID-19 vaccine Covaxin by Bharat Biotech and ICMR could now be launched by August.
Additionally, global COVID-19 vaccine candidates like Oxford-Astrazeneca’s ChAdOx1 nCoV-19, CanSino BioTech’s SinoVac, and Moderna Inc.’s mRNA 1273, are in advanced stages of human trials currently.
Zydus Cadila’s COVID19 Vaccine Gets DGCI Approval For Human Trials, Human clinical trials for the COVID19 vaccine by Zydus Cadila gets DCGI approval.